Phase II trial of pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer

Phase II trial of pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer - Phase II trial of pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024477

Enrollment

Registered

2016-10-19

Start date

2016-10-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Pertuzumab:420mg/body intravenously administred on day 1 every 3 weeks (loading dose:840mg/body) Trastuzumab:6mg/kg intravenously administred on day 1 every 3 weeks (loading dose:8mg/kg) S-1:80 mg

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Histopathologically proven diagnosis of breast cancer 2.Advanced or metastatic recurrent breast cancer 3.HER2-positive(3+ staining by IHC or HER2 gene amplification by FISH)metastatic breast cancer 4.The criteria for previous treatment as following: (1)chemotherapy: more than 7 days passed after chemotherapy (2)hormonal therapy: more than 7 days passed after hormonal therapy (3)radiation: more than 14 days passed after radiation 5.No prior treatment by S-1 for present primary breast cancer 6.Patients with measurable lesion 7.Age at consent is >= 20 8.ECOG performance status 0 to 2 9.Expected survival longer than 3 months 10.Sufficient functions of important organs WBC>=3,000/mm3 <=12,000/mm3 Neurtophils>=1,500/mm3 Platelets>=100,000/mm3 Hemoglobin>=9.0g/dL Total bilirubin <= ULN AST(GOT)<= ULNx2.5(<= ULNx5.0 in case of liver metastasis) ALT(GPT)<= ULNx2.5(<= ULNx5.0 in case of liver metastasis) Serum Creatinine<=ULN Creatinine clearance >=50mL/minutes 11.Left ventricle ejection fraction 50 % or more by cardiac sonography or MUGA scan 12.All of HBs antigen, HBs antibody, HBc antibody and HCV antibody are negative 13.Written informed consent to participate

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity reaction 2.Brain metastasis 3.Pleural effusion, ascites, and pericardial fluid requiring treatment 4.Active another cancer 5.Active infection 6.Other severe complications, such as heart failure, interstitial pneumonia and renal failure with clinically problem 7.Required treatment with steroid 8.Pregnant or possibility pregnancy or nursing women 9.Mental disorder which become problem on clinical practice 10.Physician judged improper to entry this trial

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Progression-free survival Overall survival Safety	—

Countries

Japan

Contacts

Public ContactToh Uhi

Kurume University School Department of Surgery

utoh@med.kurume-u.ac.jp0942-31-7566

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026